A House Committee on Oversight and Reform hearing sharply criticizes consulting firm McKinsey and Co. for its role in advising Purdue Pharm during the...
PhRMA cites FDA statistics to support its position that the Federal Trade Commission and Department of Justice dont need new ways to evaluate how drug...
FDA says Pfizer is recalling five lots of Accupril due to the presence of a nitrosamine above the acceptable daily level.
FDA says it is interested in working with Congress to find a legislative solution, most likely a bill that would be added to the user fee reauthorizat...
Federal Register notice: FDA sends to OMB an information collection revision entitled Expanded Access to Investigational Drugs for Treatment Use.
Janssen asks a New York federal court to stop several drug wholesalers from selling counterfeit versions of the companys HIV drugs.
FDA publishes a guidance with general information on the electronic submission of specified postmarketing safety reports to CBER and CDER.
FDA says it is evaluating reports of an increased risk of airway obstruction associated with two Medtronic silicone-based EMG endotracheal tubes.